Biogen is seeking a qualified candidate for the role of Senior III digital device integration engineer in the Device Design and Process Development group. The position will lead the novel technology area of digital experience and adherence within devices and packaging, with patient centric focus, aligned to the drug pipeline, as well as execute deliverables with internal stakeholders and external partners for Biogen, for the device and packaging products in Biogen’s portfolio.
This role bridges the enterprise operation of end-to-end discovery through regulated clinical trial to commercial application in the neuroscience portfolio at Biogen. The successful candidate will have industry experience and evidence of innovation applying novel technologies in the measurement outputs and patient centric adherence and compliance solutions.
- Lead efforts in device and packaging digital experience and adherence solutions
- Create and evaluate mechanical/electromechanical/software concepts/prototypes with user unmet needs and relevant technology
- Optimize design concepts to improve performance for usability and design robustness
- Test systems on bench top models, during design verification and human subjects testing
- Analyze designs for function, assembly, manufacturability, etc. using both CAE and Engineering techniques related to Design For Six Sigma
- Liaise with third parties such as specialist design/development firm or device/packaging manufacturers
- Evaluate external device and packaging landscape for innovative and implementable solutions for disease monitoring, adherence, and compliance
- Create and develop Intellectual Property in design and utility device and packaging space
- Communicate effectively, both verbally and in writing, internally across departments and with external suppliers
- Ensure all designs function as required and comply with the Company’s quality assurance requirements as well as applicable regulatory requirements.
- Interact with the Biogen Healthcare Solutions (BHS), PHRAS (Personalized Health Research, Analytics & Solution) and DQM (Digital Quantitative Medicine) within Biogen.
- PhD with 8+ years, MS with 8-10 years or Bachelor’s with 10-12 years’ experience in medical device design, electromechanical and sensor technology, wearables with degree in Mechanical or Electrical Engineering.
- Deep understanding of design and development of device products with digital context.
- Deep knowledge of the regulatory and compliance requirements of combination product and digital device solution in US, EU and other regions
- Experience with SaMD, SiMD, wireless connectivity, cybersecurity
- Demonstrated ability to facilitate the interface between the pharmaceutical company and the medical device, packaging vendor base
- Experience developing multiple device and packaging products from research through registration and launch.
- Strong communication, collaboration and team building skills; ability to connect with all levels of the organization
- Comfortable working in a matrix environment, while embracing and driving change